Actively Recruiting
Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
18
Participants Needed
11
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety and tolerability of olaparib in combination with durvalumab and radiation therapy in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. The combination of targeted therapy with olaparib, immunotherapy with durvalumab and radiation therapy may stimulate an anti-tumor immune response and promote tumor control in locally advanced unresectable pancreatic cancer.
CONDITIONS
Official Title
Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pancreatic cancer (excluding islets, not otherwise specified)
- Unresectable locally advanced pancreatic cancer as determined by multidisciplinary tumor board or failed surgery
- Prior first-line chemotherapy for at least 16 weeks without progression, with at least 2 weeks washout
- Age 18 years or older
- Body weight over 30 kg
- ECOG performance status 0 or 1 (Karnofsky 70% or higher)
- Hemoglobin at least 9.0 g/dL without recent blood transfusion
- Absolute neutrophil count at least 1,500/mcL
- Platelet count at least 100,000/mcL
- Total bilirubin at most 1.5 times institutional upper limit of normal
- AST/ALT at most 2.5 times institutional upper limit of normal
- Creatinine at most 1.5 times institutional upper limit of normal
- Measured creatinine clearance above 60 mL/min/1.73 m²
- Post-menopausal status or negative pregnancy test for pre-menopausal women, with specific criteria depending on age
- Life expectancy of at least 16 weeks
- Stable HIV infection with undetectable viral loads and CD4 counts above specified thresholds
- Controlled hepatitis B or cured hepatitis C infection
- Prior or concurrent malignancy allowed if not interfering with study
- Willingness to provide archived tissue if available
- Radiographically measurable or evaluable disease per RECIST v1.1
- Ability to tolerate CT and/or MRI with contrast
- Cardiac function assessment showing NYHA class 2B or better
- Use of effective contraception for men and women of childbearing potential
- Ability and willingness to sign informed consent
You will not qualify if you...
- Prior upper abdominal radiotherapy
- Unresolved grade 2 or higher adverse events from prior cancer therapy, except alopecia, vitiligo, and specified lab values
- Major surgery within 28 days before enrollment (except palliative local procedures or non-resection laparoscopy/laparotomy)
- Use of immunosuppressive medication within 14 days before durvalumab, with some exceptions
- Receipt of live attenuated vaccine within 30 days before study therapy
- Participation in other investigational drug studies
- Allergic reactions to olaparib, durvalumab, or similar compounds
- Significant medical conditions posing unreasonable risk
- Use of CYP3A4/5 inhibitors or inducers without required washout
- History of organ or allogeneic transplantation
- Germline BRCA1 or BRCA2 mutation
- Prisoners or involuntarily incarcerated individuals
- Prior anti-PD-1/PD-L1 or PARP inhibitor treatment for this cancer
- Myelodysplastic syndrome or acute myeloid leukemia
- Pregnancy or breastfeeding
- Active or suspected autoimmune diseases requiring systemic immunosuppression, with some exceptions
- Serious uncontrolled medical or systemic diseases including severe heart conditions
- Active inflammatory gastrointestinal diseases or conditions limiting drug absorption
- Active infections including tuberculosis, hepatitis B with positive antigen, or hepatitis C
- Resting ECG showing uncontrolled cardiac conditions or congenital long QT syndrome
AI-Screening
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Trial Site Locations
Total: 11 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
5
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, United States, 48116
Suspended
7
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
8
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
9
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
10
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
11
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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